PNK

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

Product code

PNK

Device name

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification definition

A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).

Definition text from the FDA device classification database (U.S. federal government work, public domain).